UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025201 |
|---|---|
| Receipt number | R000028995 |
| Scientific Title | Exploratory Research for the therapy of Endobronchial ultrasound-guided transbronchial ethanol injection. |
| Date of disclosure of the study information | 2016/12/09 |
| Last modified on | 2016/12/09 16:33:57 |
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Basic information
Public title
Exploratory Research for the therapy of Endobronchial ultrasound-guided transbronchial ethanol injection.
Acronym
Exploratory Research for the therapy of EBUS-TBEI.
Scientific Title
Exploratory Research for the therapy of Endobronchial ultrasound-guided transbronchial ethanol injection.
Scientific Title:Acronym
Exploratory Research for the therapy of EBUS-TBEI.
Region
| Japan |
Condition
Condition
Airway obstruction due to lung cancer or metastatic lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate efficacy and safety of Endobronchial ultrasound-guided transbronchial ethanol injection therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The presence or absence of improvement in the airway obstruction.
Key secondary outcomes
Size change of ethanol injected tumor.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
ethanol injection
0.2-0.4ml injection each time
total maximum 2ml
Repeat once or twice a week
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Definitive diagnosis of lung cancer or metastatic lung tumor by the tissue examination or cytology.
2 unresectable and radical irradiation inability
3 More than one month of survival can be expected
4 Cases that the airway is constricted
5 Informed consent must be taken
Key exclusion criteria
1 Cases that can be treated by only irradiation.
2 The doctor's disagrement for the registration due to some underlying medical conditon
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikio Takamori |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of respiratory medicine and clinical oncology
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
042-323-5111
mikio_takamori@tmhp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikio Takamori |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of respiratory medicine and clinical oncology
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
042-323-5111
Homepage URL
mikio_takamori@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Department of respiratory medicine and clinical oncology
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Tama Medical Center
Department of respiratory medicine and clinical oncology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京都立多摩総合医療センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 09 | Day |
Last modified on
| 2016 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028995
